Global Regulatory Lead, Immunology (Remote)

Merck; Harrisburg (Dauphin County); Remote; USD 191,000 - 300,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Healthcare benefits

401(k)

Job summary

Merck & Co., Inc. in the United States seeks a Senior Director, Regulatory Affairs Liaison to lead worldwide regulatory strategies for General Medicine immunology programs.

You will serve as the global regulatory lead on project teams and interact with FDA, EMA, and other agencies to optimize labeling and accelerate approvals. The role requires strategic thinking, independence, and leadership of cross-functional teams, with a strong immunology regulatory background and excellent communication

Qualifications

• BS or MS with extensive drug development experience focused on regulatory
• MD/PhD/PharmD with regulatory leadership experience

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and speed approvals.
• Global Regulatory Lead for Product Development Teams and regulatory single point-of-contact.
• Coordinates submissions and regulatory communications with agencies (FDA, EMA).
• Leads cross-functional regulatory teams across programs and indications.
• Interacts with health authorities and leads advisory committee preparation.

Job description

Merck & Co., Inc. in the United States seeks a Senior Director, Regulatory Affairs Liaison to lead worldwide regulatory strategies for General Medicine immunology programs.

You will serve as the global regulatory lead on project teams and interact with FDA, EMA, and other agencies to optimize labeling and accelerate approvals. The role requires strategic thinking, independence, and leadership of cross-functional teams, with a strong immunology regulatory background and excellent communication